Is NCT07218354 recruiting in Orlando, FL?

Yes, NCT07218354 is currently enrolling participants at its Orlando, FL location. This alcohol use disorder clinical trial is accepting qualified participants.

How do I join the alcohol use disorder clinical trial in Orlando?

To join this clinical trial in Orlando, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Orlando clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Alcohol Use Disorder Clinical Trial in Orlando, FL: Semaglutide (Phase 3)

About This Alcohol Use Disorder Study in Orlando

This clinical trial aims to test the effectiveness and safety of semaglutide, a GLP-1 receptor agonist, in treating moderate to severe alcohol use disorder (AUD) in Veterans. Participants who qualify will be randomly assigned to receive either semaglutide injections or placebo injections over a 28-week period, followed by a 4-week post-treatment safety assessment period. Participants receiving semaglutide will start with a low dose, gradually increasing to a maximum of 2.4 milligrams (mg) per week, depending on their tolerance. The primary measure of success will be a reduction in risky drinking, assessed through a reliable calendar-based interview method called the Timeline Follow-Back (TLFB), a well-validated calendar-based interview technique for recording daily alcohol consumption. The purpose of this research is to gather information on the effectiveness of semaglutide for treating AUD, potentially offering a new and more appealing treatment option.

Sponsor: VA Office of Research and Development

Who Can Participate

Inclusion Criteria

WHO risk drinking level of Very High or High in the 28 days prior to screening

Current diagnosis of moderate or severe AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria) based on semi-structured diagnostic exam

Able and willing to provide informed consent

Has a desire to reduce their alcohol consumption

Exclusion Criteria

Medical and Psychiatric:

Type 1 diabetes

Current serious psychiatric illness (any psychotic disorder, bipolar 1 disorder, psychotic major depression, antisocial personality disorder, bulimia, or anorexia)

Current DSM-5 diagnosis of a SUD (other than moderate-to-severe alcohol, any nicotine, or mild cannabis use disorders)

At the time of randomization, moderate-to-severe alcohol withdrawal (Clinical Institute Withdrawal Assessment for Alcohol (CIWA-AR) \>8)

Body mass index (BMI) \<21 kg/m2

Unstable body weight defined as \>5% change in body weight (documented or self-report; intentional or not) in the 90 days prior to randomization

History of acute or chronic pancreatitis

History of diabetic ketoacidosis

History of proliferative diabetic retinopathy

History of ascites, advanced liver fibrosis, compensated cirrhosis with portal hypertension, decompensated cirrhosis, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or hepatocellular carcinoma (HCC)

History of stage 3 fibrosis or stage 4 cirrhosis from a liver biopsy

Presence of gastroparesis

History of acute gallbladder disease in the prior 6 months

History of advanced fibrosis or cirrhosis, including (but not limited to) transient elastography (liver stiffness) of \>12 kPa, FIB-4 \>= 2.67, ELF \>= 9.8, MRE \>= 3.63 kPa

History of esophageal varices on endoscopy or imaging

History of nodular liver, cirrhosis, splenomegaly, varices or splenic venous shunting or collaterals on prior imaging

History or acute alcohol hepatitis (by liver biopsy or elevated bilirubin \> 1.5 times the upper limit of normal)

History of primary biliary cholangitis

History of primary sclerosing cholangitis

History of autoimmune liver disease

History of hemochromatosis

History of Wilson's disease

History of alpha1 antitrypsin deficiency related liver disease

Current drug-induced liver disease

Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)

Acute high risk of suicide requiring hospitalization at the time of screening or randomization

Medical, psychiatric, behavioral, or logistical conditions which, in the judgement of the Local Site Investigator (LSI) or Co-Investigator (Co-I), make it unlikely the participant can participate in or complete the 24-week active phase of the study

Recent major cardiovascular event in the 90 days prior to randomization (myocardial infarction, stroke, New York Heart Association class IV heart failure, transient ischemic attack (TIA), or unstable angina Laboratory

Hemoglobin A1c (HbA1c)\>10

Estimated glomerular filtration rate (eGFR) \<30 mL/min

Albumin \< 3.5 g/dl

Aspartate aminotransferase (AST) \>3 the Upper Limit of Normal (ULN)

Alanine aminotransferase (ALT) \>3 the ULN

Lipase \> 2 times the upper limit of normal

Alkaline phosphatase \> 1.5 times the ULN

Total bilirubin \> 1.5 times the ULN except with documented Gilbert's syndrome

International Normalized Ratio (INR) \> 1.3 unless due to anticoagulation therapy

Platelet count \<150,000/µL unless consistent with baseline and reflects the participant's habitual thrombocyte level, and there was no presence of portal hypertension

Hepatitis B surface antigen positive

Hepatitis C virus RNA positive - participants treated and cured of hepatitis C must have at least 2 years of negative testing

Anti-HIV antibody positive test with uncontrolled or unstable treatment

Positive urine drug screen for substances other than cannabis and prescribed medications

Positive urine pregnancy test at screening in those considered of childbearing potential Concurrent Treatments:

Current (within the past 30 days) use of pharmacotherapy for AUD (including oral or intramuscular naltrexone, acamprosate, disulfiram, topiramate)

Known history of prior hypersensitivity reaction to semaglutide, any of the product components, or any other GLP-1 analogue

Current (within the past 30 days) use of the following medications with glucose-lowering properties: GLP-1 analogues; sulfonylurea; insulin and insulin products; dipeptidyl peptidase-4 (DPP-4) inhibitors; sodium-glucose cotransporter-2 (SGLT-2) inhibitors, meglitinides, thiazolidinediones or other medications that may interact with semaglutide

Recent changes in dose (within 2 months of randomization) of psychiatric medications (i.e., antidepressants, antianxiety, mood stabilizing) Other

Pregnant, actively breastfeeding, or female of childbearing potential who is unwilling to use a highly effective method of contraception as defined by the NIH

Currently enrolled in another therapeutic or investigational clinical trial

Participant is incarcerated

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orlando?

Yes, this clinical trial (NCT07218354) has an active research site in Orlando, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Alcohol Use Disorder Treatment Options in Orlando, FL

If you're searching for alcohol use disorder treatment options in Orlando, FL, this clinical trial (NCT07218354) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orlando research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced alcohol use disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all alcohol use disorder clinical trials near you to find additional studies recruiting in your area.

Alcohol Use Disorder Clinical Trial in Orlando, FL

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